This course introduces students involved in clinical research to the practical application of regression analyses. Linear regression, logistic regression, and proportional hazards survival models are covered, as well as general concepts in model selection, goodness-of-fit, and testing procedures. Each lecture is accompanied by a data analysis using SAS and a classroom discussion of the results. The course introduces but does not attempt to develop the underlying likelihood theory and uses as little calculus as possible. Upon completion of the course the student should be able to carry out his/her own multiple linear and logistic regression analyses and will have had an introduction to Cox regression as well.

The success of the Human Genome Project has placed powerful tools in the hands of clinical investigators, offering an opportunity to explore the roles of genes in the pathogenesis of both rare and common disorders, eventually leading to the development of new approaches to diagnosis, prevention, and treatment. The primary goals of the course are to teach clinical researchers to (1) recognize opportunities to address genetic questions in clinical studies, (2) appreciate the major approaches to research in genetics, and (3) understand the basics of study design and data analysis. Students will become familiar with how the genetic contribution to a phenotype can be recognized, basic principles of population genetics, technical approaches to genotypic analysis, identification of genes and mutations and use of genetic testing, use of computer databases in genomic research, principles of ethical conduct of genetics research, parametric and non-parametric linkage analysis, association analysis, studies of gene expression, principles of pharmacogenetics, and integration of genetics into medical practice.

This course is designed to provide the opportunity for close interactions with faculty from a variety of clinical research disciplines. The goals of the course are to (1) provide students with practical information from a variety of areas relevant to patient-oriented research, (2) encourage students to apply and refine concepts learned to their ongoing clinical research projects, (3) foster the development of critical thinking in the art and science of clinical investigation, and (4) sharpen skills in the development and conduct of patient-oriented research and in the presentation of research findings. The first eight-week period of the fall semester is a bioethics curriculum for all first-year students directed by Robert Truog, MD. A mock study section, which allows students to review grant applications, is conducted in the spring semester.

This course serves as a basic course in clinical pharmacology with application to clinical and translational research. Drug discovery, unmet clinical needs, pre-clinical development, clinical investigation, and manufacturing and regulatory issues are considered, with applications to diseases including cancer, diabetes, and AIDS. The course covers an intensive two-week period wherein lectures, invited speakers, case studies, problem sets, journal clubs, and group projects represent the principal teaching modalities. Case studies presented by industry executives provide a hands-on, real-world approach to how pharmaceuticals are developed in the real world and to ethical issues relative to the industry. Problem sets are designed to reinforce basic concepts and quantitative aspects, and journal clubs are designed to promote critical, close reading of the drug case studies and development literature. Facilitated group projects afford students the opportunity to work in teams in a collaborative environment that reflects the manner in which drugs are currently designed. The first third of the course provides students with basic pharmacological principles and concepts and their molecular underpinnings. The second third of the course teaches modern methods used to discover and design new drugs. The last third explores pharmaceutical industry issues, pharmacoeconomics, and pharmacovigilance.

This course is designed for students interested in the scientific, policy, and management aspects of clinical trials. The course provides a comprehensive discussion of clinical trials including first studies in humans (dose-finding, safety, proof of concept, Phase I), Phase II, and Phase III studies. Students are given homework assignments exploring key ideas, critique recently published medical literature, and take mid-term and final examinations focusing on key concepts discussed in the course.

The mentored clinical research project is a plan of mentor-guided independent study wherein the student works closely with a Harvard Medical School faculty mentor in pursuing hypothesis-driven clinical research in the area of translational biomedicine (e.g., human physiology, pathophysiology, genetics), clinical trials, or clinical pharmacology. The mentor supervises the research project at the Harvard teaching hospital with which s/he is affiliated. In conjunction with the didactic component of the curriculum, the research project offers the student the opportunity to generate new knowledge within his/her subspecialty by learning the principles, techniques, and practical methods of clinical research and conducting a research project. The project culminates in a master's thesis submitted as both a written document and oral presentation.

This course explores how technological and scientific breakthroughs occur and how to move an idea from the lab to the market. The broad area of interest is biomedicine, which includes therapeutics, molecular diagnostics, medical devices, drug delivery technologies, bioinformatics platforms, novel technologies supporting the R&D process (e.g., toxicology), as well as the emerging field of mobile applications for healthcare. Students work in cross-disciplinary teams to develop commercialization plans for breakthroughs in biotechnology, nanotechnology, information technology, and clean technologies. Students learn where a breakthrough is most likely to occur and how to increase an organization's chances of inventing one. Students (1) assess the strategy and tactics that are necessary for science-based businesses to thrive, (2) evaluate what makes an effective science-business leader, (3) explore the strategic, operational, and ethical issues that arise in the development of companies that aim to commercialize breakthrough innovation, and (4) invent and execute both profit and not-for-profit business models, based on Harvard breakthroughs. The course culminates in a Project Fair in December. Projects from this course have gone on to compete successfully in business plan competitions at both Harvard and MIT.

This course continues in Year 2 to provide the opportunity for close interactions with faculty from a variety of clinical research disciplines. The goals of the course are to (1) provide students with practical information from a variety of areas relevant to patient-oriented research, (2) encourage students to apply and refine concepts learned to their ongoing clinical research projects, (3) foster the development of critical thinking in the art and science of clinical investigation, and (4) sharpen skills in the development and conduct of patient-oriented research and in the presentation of research findings.

The mentored clinical research project is a plan of mentor-guided independent study wherein the student works closely with a Harvard Medical School faculty mentor in pursuing hypothesis-driven clinical research in the area of translational biomedicine (e.g., human physiology, pathophysiology, genetics), clinical trials, or clinical pharmacology. The mentor supervises the research project at the Harvard teaching hospital with which s/he is affiliated. In conjunction with the didactic component of the curriculum, the research project offers the student the opportunity to generate new knowledge within his/her subspecialty by learning the principles, techniques, and practical methods of clinical research and conducting a research project. The project culminates in a master's thesis submitted as both a written document and oral presentation.

Upon completion of the program each Scholar submits a thesis, which can take the form of either a traditional master's thesis or two research papers of publishable quality on which the Scholar is first author.

Although the current curriculum of required courses and the mentored clinical research project constitute a full course load for most Scholars, some students choose to take one or more electives--courses into which they may cross-register without incurring additional tuition or fees. If a student wishes to take an elective course for credit, s/he should keep in mind that the course must be completed with a satisfactory grade in order for the student to receive a diploma from Harvard. Scholars may take only those elective courses that do not interfere with the schedule of required courses.